The FDA has issued final guidance on definitions of suspect and illegitimate product under the Drug Supply Chain Security Act. Specifically, the agency is clarifying its interpretation of the terms counterfeit, diverted, stolen, fraudulent transaction, and unfit for distribution to aid pharmacies and other stakeholders in determining whether a product is suspect and/or illegitimate. Although this guidance does not create an exhaustive list of the circumstances that may result in a counterfeit drug, a diverted drug, a stolen drug, a fraudulent transaction, or a drug that is unfit for distribution, it describes the most common scenarios that FDA believes trading partners will encounter.
NCPA
